[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627875":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Liverpool John Moores University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1- Biofeedback intervention + standard care","EXPERIMENTAL","If allocated to the intervention group, you will be sent a smartwatch and device introduction pack with information on how to download a custom mobile application named Motivate-cloud and the Polar Flow mobile application, with instructions on how to sync your Polar device. Once set up, you will wear the smartwatch device for 6-months that records heart rate and physical activity. During this time, you will be sent regular text messages with motivating information on your activity (steps, time sitting, standing and moving) and AF. \\*Important note: when we send you messages regarding your risk of AF, this is based on your heart rate variability (i.e. the variation in time between heart beats), and based on this variation, we predict we can determine whether the risk of being in AF has gone up or down for a given period of time.\\*",[13],"Behavioral: Biofeedback intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Standard care","NO_INTERVENTION","You would have had a conversation about the benefits of lifestyle and physical activity with your direct health care team prior to agreeing to receiving contact with the research team. If you are allocated to this group, you will continue with usual medical treatment for your atrial fribrillation as determined by your healthcare team. You will receive adequate information and support, lifestyle advice about smoking, exercise, diet, and weight control.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Biofeedback intervention","Participants wearing a smartwatch will receive feedback on their paroxysmal atrial fibrillation and physical activity. This feedback will hopefully nudge them to become more physically active.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Luca J Howard","CONTACT","+ 151 231 2121","l.j.howard@ljmu.ac.uk",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Benjamin Buckley","0151 231 2121","B.J.Buckley@ljmu.ac.uk",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Liverpool","Merseyside","L3 3AF","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-2.97794,53.41058,{"lat":47,"lon":46},[50],{"name":27,"role":28,"phone":51,"phoneExt":18,"email":30},"+44 151 231 2121",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[55],{"name":56,"class":6},"Liverpool Heart and Chest Hospital NHS Foundation Trust","100627875","biofeedback-intervention-for-paroxysmal-atrial-fibrillation-100627875",false,"NCT07454317","Biofeedback Intervention for Paroxysmal Atrial Fibrillation","Remote Physical Activity Biofeedback Intervention for Patients With Paroxysmal Atrial Fibrillation Using Mobile Health Technology.","BI-PAF","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 or over.\n* Diagnosed with paroxysmal AF\n* Deemed medically stable and well managed.\n\nExclusion Criteria:\n\n* Any concurrent cardiac arrhythmia\n* Blood pressure \\>180\u002F100\n* Unstable angina\n* Myocardial infarction within the previous 3 months\n* Valvular heart disease\n* Heart failure NYHA class 4\n* \\\u003C6 months post-transplant\n* Resting\u002Funcontrolled tachycardia\n* Stroke in last 6 weeks\n* Cardiac sarcoidosis\n* Injury or disability preventing exercise","ALL","18 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is:\n\nIs a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial?\n\nThe trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods.\n\nPhase 1 Co-design and usability testing:\n\nIn this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active.\n\nParticipants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days.\n\nPhase 2 Feasibility study with embedded process evaluation:\n\nThis phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful).\n\nParticipants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.",[75],"Atrial Fibrillation (Paroxysmal)",[77,78,79,80,81,82],"Atrial fibrillation","Physical activity","Behavioural economics","Nudge theory","Wrist worn technology","mHealth","2026-05-20",{"date":85,"type":86},"2026-05-22","ACTUAL",{"date":88,"type":86},"2026-04-15",{"date":90,"type":69},"2028-02-01",{"name":5,"class":6},1]